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Job Description
The Quality Lab Leader is responsible for managing the final batch release and complaints processes for commercial products, including outsourced activities.
Key Responsibilities:
- Manage the startup and implementation of the Quality laboratory and the qualification of lab equipment, processes, and/or test methods related to product release and complaints testing.
- Identify product defects and potential issues, analyze data, and trend results.
- Support the continuous improvement of testing and/or quality assurance processes, provide technical support on equipment and methods, and manage complex issues with a high level of autonomy.
- Set priorities for the Quality lab and be accountable for the success of all deliverables, ensuring related operations follow applicable BD policies and procedures, as well as applicable regulations and standards.
General Lab Responsibilities:
- Identify and evaluate new and/or equipment improvements.
- Responsible for purchasing, installation, and validation of equipment.
- Serve as technical expert regarding general laboratory instrumentation, equipment, and processes.
- Manage and maintain on-time calibration and preventive maintenance of laboratory equipment.
- Communicate with suppliers to drive on-time completion of activities.
- Coordinate repairs and remediation activities, as needed.
- Drive investigation activities for out of specification (OOS) calibration results.
- Support test method and fixture development, as needed.
- Maintain laboratory safety and organization, as well as operational and functional conditions.
- Manage inventory and related documentation, including laboratory supplies, test samples, and chemicals.
- Identify and implement continuous process improvements in the laboratories, as well as contribute to lab network initiatives.
- Lead or contribute to root cause investigations and corrective/preventive actions, as needed.
- Identify and support qualifications of new lab suppliers, when needed.
- Support Supplier Quality team with maintenance activities for existing suppliers.
- Ability to work effectively in project teams, as needed.
- Assist with failure or non-conformance investigations.
- Support audits (regulatory, customer, internal) as a subject matter expert.
- Perform internal audits and compliance assessments, when needed.
- Lead change management activities for lab processes.
- Supervise technicians performing complaints and/or release activities.
- Conduct on-boarding and ongoing training program of lab associates.
- Maintain good laboratory practices (GLP) consistent with corporate and regulatory guidelines.
- Maintain good documentation practices (GDP) when generating test data and records in accordance with ISO, cGMP, and other applicable regulations and standards.
Complaints Management:
- Manage and drive completion of commercial product complaints activities: planning, sample management, investigations, reporting, oversight of activities performed by support team(s) and/or supplier(s).
- Perform complaint Quality Data Analysis, as needed.
- Identify and report trends and/or triggers for significant complaint issues.
Product Release:
- Perform final product release operations.
- Maintain documentation, review inspection results, and disposition product.
- Initiate or perform non-conformance investigations, if needed.
- Trend incoming inspection data, as needed.
- Identify and report trends and/or triggers for initiating supplier complaints.
About the Role:
The Quality Lab Leader will be responsible for managing the Quality laboratory, including the qualification of lab equipment, processes, and/or test methods related to product release and complaints testing. The ideal candidate will have a strong background in quality control, laboratory management, and technical expertise in mechanical measurement and testing equipment.
About the Company:
BD is a global medical technology company that is committed to advancing the world of health. Our Purpose is to help people live healthier, fuller lives, and we are dedicated to delivering innovative solutions that make a meaningful difference in the lives of our customers and patients.
Requirements:
- Bachelor's degree in Engineering, Science, or other related discipline.
- Up to 5 years of experience in a similar role, or equivalent: Pharmaceutical, medical device, diagnostics, or Quality Control.
- Knowledge of the operation of mechanical measurement and testing equipment (e.g. Instron) and CT scanners.
- Understanding of industry standards and regulations such as ISO, FDA, OSHA, ASTM.
- Excellent written and oral communication skills.
- Superior attention to detail.
- General knowledge of problem-solving and root cause analysis methodology.
- General knowledge of statistical techniques.
- Ability to handle multiple tasks/projects simultaneously under general supervision.
- Ability to work with diverse, multi-national, cross-functional teams.